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RECRUITING
NCT06675864
PHASE1/PHASE2

Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is an open-label, multi-center, non-confirmatory study to assess the safety, disease progression, and cellular kinetics following YTB323 administration to 28 participants with non-active Progressive Multiple Sclerosis (PMS). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.

Official title: An Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression, and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2024-12-12

Completion Date

2030-06-14

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

rapcabtagene autoleucel (YTB323)

CAR-T cell suspension for intravenous infusion

Locations (17)

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Bron, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Nancy, France

Novartis Investigative Site

Rennes, France

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Ulm, Germany

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Majadahonda, Madrid, Spain

Novartis Investigative Site

Málaga, Spain

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Lausanne, Switzerland

Novartis Investigative Site

Zurich, Switzerland